Alcohol Use, UnspecifiedNCT05235971
Behavioral Economic Treatment to Enhance Rural (BETTER) Living
A study testing Episodic Future thinking, Volitional choice and Monitoring only in people with Alcohol Use, Unspecified, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this trial is to get feedback to help develop programs delivered by phone and text messages to improve wellness and health behaviors. This study will enroll adult participants that have been seen in primary care settings and live in rurally designated areas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use, Unspecified
- What is being tested?
- Episodic Future thinking, Volitional choice and Monitoring only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2022to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Does not understand English
- currently pregnant
- unable to provide informed consent due to medical/psychiatric reasons
- currently in treatment for a substance use disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral Economic Treatment to Enhance Rural Living
The purpose of this trial is to get feedback to help develop programs delivered by phone and text messages to improve wellness and health behaviors. This study will enroll adult participants that have been seen in primary care settings and live in rurally designated areas.
Read the detailed description
This study will evaluate acceptability and feasibility of two remotely-delivered behavioral economic intervention components, alone and in combination, using remote text message delivery. The two intervention components are an episodic future thinking component and a volitional choice component. The goal of this work is to develop and determine acceptability and feasibility of a well-specified, accessible, and theory-driven mobile health intervention to reduce harmful alcohol use in people living in rural regions.
- Conditions
- Alcohol Use, Unspecified
- Being tested
- Episodic Future thinking, Volitional choice, Monitoring only
- Keywords
- Heavy alcohol consumption, Alcohol misuse
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episodic Future thinkingBehavioural
During a visit with the study team, participants will identify personally-relevant reminders, or cues, that they will receive up to 3 messages a day via text-message over a two-week period.
The messages will describe positive, non-alcohol related events at future time points to facilitate extension of temporal consideration toward future-focused perspectives.
In addition, participants will have phone meetings (video or not) where health behaviors as well as survey information is noted and collected
Volitional choiceBehavioural
Volitional choice creates structured if-then plans to dismantle context-linked alcohol use The messages sent over a two-week period facilitate alternative, healthier choices by identifying and linking risky cues with alternative actions. Participants will receive up to 3 messages a day for 14 days that include assessment and intervention messages.
In addition, participants will have phone meetings (video or not) where health behaviors as well as survey information is noted and collected.
Monitoring onlyBehavioural
Participants will receive general psychoeducation about alcohol use, mental health, resources, and a description of the assessments to be completed over a two-week field testing period.
In addition, participants will have phone meetings (video or not) where health behaviors as well as survey information is noted and collected.
| Study group | Role | What they receive |
|---|---|---|
| Episodic Future thinking (EFT) | Experimental | Participants will receive up to 3 messages a day that include assessment and intervention messages.The messages will describe positive, non-alcohol related events at future time points to facilitate extension of temporal consideration toward future-focused perspectives. Receives: Behavioral: Episodic Future thinking |
| Volitional choice (VC) | Experimental | VC creates structured if-then plans to dismantle context-linked alcohol use. Participants will receive up to 3 messages a day that include assessment and intervention messages. Receives: Behavioral: Volitional choice |
| Episodic Future thinking plus Volitional choice | Experimental | Participants will receive both EFT and VC interventions with text messages. Receives: Behavioral: Episodic Future thinking; Behavioral: Volitional choice |
| Monitoring only | Other | This is a control group in which participants will receive general psychoeducation. Receives: Behavioral: Monitoring only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Intervention - Screening
Percent of participants who complete intervention phone call
Measured: Day 1 of Intervention
Feasibility of the Intervention - Enrollment
Percent of participants who elect to receive text messages
Measured: Day 1 of Intervention
Intervention Acceptability: Number of Participants Who Rated the Intervention as Acceptable
Number of participants with positive acceptability ratings who indicated enjoying the intervention at least a little bit. In a phone survey, participants were asked to rate their enjoyment of the intervention on a scale of 1-5, where 1 was "not at all" and 5 was "extremely". Scores of 2 ("a little bit") or more were considered to be positive indicators of acceptability.
Measured: 2 Weeks Post-Intervention
Secondary outcomes (1)
Alcohol Consumption
Average number of standard drinks consumed during the 2-week intervention period per person. A "standard drink" was considered to be 12 oz beer, 1.5 ounce shot of liquor, or 5 oz glass of wine.
Measured: The 2 weeks (14-days) of the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start17 May 2022
- Primary completion8 May 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use, UnspecifiedStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Lara Coughlin, University of Michigan
- Investigators
- Lara Coughlin, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235971
- Sponsor's protocol ID
- HUM00181940
- Other IDs
- 1K23AA028232
- Status last verified
- Mar 2025
- First submitted
- 1 Feb 2022
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hellman L, Wilkins C, Bayrakdarian N, Jannausch M, Bonar EE, Walton MA, Lin LA, Staton M, Coughlin L. Rural- and nonrural-specific themes in personalized intervention messages for adults with at-risk alcohol use living in rural areas. Exp Clin Psychopharmacol. 2026 Feb;34(1):8-17. doi: 10.1037/pha0000830.
PubMed 41538227
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Economic Treatment to Enhance Rural Living
- ClinicalTrials.gov ID
- NCT05235971
- Acronym / sponsor ID
- HUM00181940
- Conditions
- Alcohol Use, Unspecified
- Keywords
- Heavy alcohol consumption, Alcohol misuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 17 May 2022 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Posted 10 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to get feedback to help develop programs delivered by phone and text messages to improve wellness and health behaviors. This study will enroll adult participants that have been seen in primary care settings and live in rurally designated areas.
Detailed description
This study will evaluate acceptability and feasibility of two remotely-delivered behavioral economic intervention components, alone and in combination, using remote text message delivery. The two intervention components are an episodic future thinking component and a volitional choice component. The goal of this work is to develop and determine acceptability and feasibility of a well-specified, accessible, and theory-driven mobile health intervention to reduce harmful alcohol use in people living in rural regions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Episodic Future thinking (EFT) | Experimental | Behavioral: Episodic Future thinkingParticipants will receive up to 3 messages a day that include assessment and intervention messages.The messages will describe positive, non-alcohol related events at future time points to facilitate extension of temporal consideration toward future-focused perspectives. |
| Volitional choice (VC) | Experimental | Behavioral: Volitional choiceVC creates structured if-then plans to dismantle context-linked alcohol use. Participants will receive up to 3 messages a day that include assessment and intervention messages. |
| Episodic Future thinking plus Volitional choice | Experimental | Behavioral: Episodic Future thinking, Behavioral: Volitional choiceParticipants will receive both EFT and VC interventions with text messages. |
| Monitoring only | Other | Behavioral: Monitoring onlyThis is a control group in which participants will receive general psychoeducation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Does not understand English
- currently pregnant
- unable to provide informed consent due to medical/psychiatric reasons
- currently in treatment for a substance use disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Episodic Future thinkingDuring a visit with the study team, participants will identify personally-relevant reminders, or cues, that they will receive up to 3 messages a day via text-message over a two-week period. The messages will describe positive, non-alcohol related events at future time points to facilitate extension of temporal consideration toward future-focused perspectives. In addition, participants will have phone meetings (video or not) where health behaviors as well as survey information is noted and collected | Behavioural | Episodic Future thinking (EFT), Episodic Future thinking plus Volitional choice |
| Volitional choiceVolitional choice creates structured if-then plans to dismantle context-linked alcohol use The messages sent over a two-week period facilitate alternative, healthier choices by identifying and linking risky cues with alternative actions. Participants will receive up to 3 messages a day for 14 days that include assessment and intervention messages. In addition, participants will have phone meetings (video or not) where health behaviors as well as survey information is noted and collected. | Behavioural | Episodic Future thinking plus Volitional choice, Volitional choice (VC) |
| Monitoring onlyParticipants will receive general psychoeducation about alcohol use, mental health, resources, and a description of the assessments to be completed over a two-week field testing period. In addition, participants will have phone meetings (video or not) where health behaviors as well as survey information is noted and collected. | Behavioural | Monitoring only |
Primary outcome
Feasibility of the Intervention - Screening
Time frame: Day 1 of Intervention
Percent of participants who complete intervention phone call
Feasibility of the Intervention - Enrollment
Time frame: Day 1 of Intervention
Percent of participants who elect to receive text messages
Intervention Acceptability: Number of Participants Who Rated the Intervention as Acceptable
Time frame: 2 Weeks Post-Intervention
Number of participants with positive acceptability ratings who indicated enjoying the intervention at least a little bit. In a phone survey, participants were asked to rate their enjoyment of the intervention on a scale of 1-5, where 1 was "not at all" and 5 was "extremely". Scores of 2 ("a little bit") or more were considered to be positive indicators of acceptability.
1 secondary outcome
Alcohol Consumption
Time frame: The 2 weeks (14-days) of the intervention period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41538227Hellman L, Wilkins C, Bayrakdarian N, Jannausch M, Bonar EE, Walton MA, Lin LA, Staton M, Coughlin L. Rural- and nonrural-specific themes in personalized intervention messages for adults with at-risk alcohol use living in rural areas. Exp Clin Psychopharmacol. 2026 Feb;34(1):8-17. doi: 10.1037/pha0000830.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara Coughlin, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Episodic Future thinking, Volitional choice and Monitoring only in people with Alcohol Use, Unspecified, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention - Screening (time frame: Day 1 of Intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05235971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.